UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053331 |
|---|---|
| Receipt number | R000060873 |
| Scientific Title | Prospective study to determine the relationship between gastrointestinal microflora and physical disease symptoms. |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/01/11 19:00:12 |
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Basic information
Public title
Prospective study to determine the relationship between gastrointestinal microflora and physical disease symptoms.
Acronym
Prospective study to determine the relationship between gastrointestinal microflora and physical disease symptoms.
Scientific Title
Prospective study to determine the relationship between gastrointestinal microflora and physical disease symptoms.
Scientific Title:Acronym
Prospective study to determine the relationship between gastrointestinal microflora and physical disease symptoms.
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Functional gastrointestinal disorders are disorders that present with abdominal symptoms in the absence of organic disease. Functional Dyspepsia, a FGID of the upper gastrointestinal tract, is found in about 15% of adults, of whom about 25% receive some form of medical care, and has an important impact on the quality of life of the patient. According to the Rome IV classification, an international diagnostic standard, FD is defined as a condition in which, despite the absence of organic disease, one or more of four symptoms thought to originate from the gastroduodenal region, namely, painful postprandial lethargy, early satiety, epicardial pain, and epicardial burning, appear at least 6 months prior to diagnosis and persist for 3 months before diagnosis. The pathophysiology of FD includes multiple possible mechanisms such as gastrointestinal motility disorders, visceral hypersensitivity, and central nervous system stress response. It is becoming clear that gastrointestinal and duodenal flora other than H. pylori infection are also associated with dyspepsia symptoms. Although it has been suggested that diet may be a cause of dyspepsia symptoms, no study has been conducted to clarify the relationship between diet and gastrointestinal and duodenal microbiota and dyspepsia symptoms because of the complexity of analyzing dietary content. Therefore, the purpose of this study is to conduct a comprehensive investigation of dietary content, gastrointestinal and duodenal microbiota, and H. pylori strain factors as factors related to dyspepsia symptoms.
Basic objectives2
Others
Basic objectives -Others
See above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of gastric and duodenal mucosal flora and dietary contents associated with dyspepsia symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients scheduled for upper gastrointestinal endoscopy at Keio University Hospital and who have given consent for this study
Patients must be at least 18 years of age.
Key exclusion criteria
1. patients who are taking antiplatelet or anticoagulant medications
2. patients who are deemed inappropriate for inclusion in the study by the physician in charge, etc.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
155-0032
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
koyamaru2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
155-0032
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
koyamaru2002@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the time of enrollment, information will be collected using medical records and questionnaires regarding disease background, treatment, and symptoms.
a. Disease background (medical record extraction)
Management information
Registered date
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060873
